Consumer medicine information

Chlorhexidine Irrigation Solution

Chlorhexidine gluconate

BRAND INFORMATION

Brand name

Pfizer (Perth) Chlorhexidine Irrigation Solution

Active ingredient

Chlorhexidine gluconate

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Chlorhexidine Irrigation Solution.

What is in this leaflet

This leaflet answers some common questions about Chlorhexidine Irrigation Solution. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you using Chlorhexidine Irrigation Solution against the benefits this product is expected to have for you.

This medicine is likely to be used while you are at the clinic or in hospital. If possible, please read this leaflet carefully before this medicine is given to you. In some cases this leaflet may be given to you after the medicine has been used.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet. You may need to read it again.

What Chlorhexidine Irrigation Solution is used for

Your doctor or nurse will use Chlorhexidine Irrigation Solution for cleansing and irrigating the skin or wounds, or to prepare your body before using a special tube to drain the bladder (catheter). It contains antiseptics that will help prevent infection.

Before you use Chlorhexidine Irrigation Solution

Do not use it after the expiry date (EXP) printed on the label. It may have no effect at all, or worse, an entirely unexpected effect if you use it after the expiry date.

Do not use Chlorhexidine Irrigation Solution if the packaging is torn or shows signs of tampering.

You must tell your doctor if you have allergies to:

  • chlorhexidine
  • any of the ingredients listed at the end of this leaflet.
  • any other substances, such as foods, preservatives or dyes

If you have an allergic reaction, you may get a skin rash

Before any Chlorhexidine Irrigation Solution is used please tell your doctor about any of these things and anything else which you feel is important.

How Chlorhexidine Irrigation Solution is used

Your doctor or nurse will normally use the irrigation to wash and clean your skin or wounds, or to clean your genital area before a special tube called a catheter is used to drain your bladder. It is for external use only and should not be injected or swallowed. It should not be used in the eyes or ears.

Your doctor or nurse will decide how much of the irrigation to use which will be sufficient for your needs. As each irrigation is sterile, your doctor will use a new solution each time.

If you are given this product to use at home it must be used as directed by your doctor or nurse. Rinse the area to be cleaned with water, then use the smallest amount of irrigation to gently wash the area. Rinse again with water thoroughly. Use a new solution each time.

Your doctor or nurse will be happy to discuss the way the Chlorhexidine Irrigation Solution will be used.

Overdose

As your doctor or nurse will administer this irrigation, they will use the correct amount. As it is for external use only, it is unlikely an overdose will occur.

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to your nearest hospital emergency department if you think that someone may have drunk Chlorhexidine Irrigation Solution or if it has been put into the eyes or ears, even if there are no signs of discomfort or poisoning.

Side effects

Chlorhexidine Irrigation Solution helps most people when used for washing and cleansing the skin or wounds, but it may have some unwanted side-effects in a few people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Tell your doctor if you experience a skin rash or reaction. If you get a skin rash it may be because you have had an allergic reaction to the irrigation. If this is the case, you should no longer use this irrigation.

Tell your doctor, nurse or pharmacist as soon as possible if you have any allergic reaction, notice any blood in the urine or feel anything unusual during or after Chlorhexidine Irrigation Solution has been used.

After using Chlorhexidine Irrigation Solution

Storage

If you have this product at home, it should be kept in the original container, in a safe place, out of reach of children. A locked cupboard at least one and a half metres above the ground is a good place to store medicines.

Chlorhexidine Irrigation Solution should be stored below 25 degrees C and protected from light.

Do not leave Chlorhexidine Irrigation Solution in the car on hot days.

Disposal

Do not exceed the stated expiry date printed on the label.

Product description

What it looks like

Chlorhexidine Irrigation Solution is a sterile, blue solution and comes in a 30 mL plastic Steritube® ampoule. Pack size: 30 units.

Ingredients

Chlorhexidine 0.1% w/v Irrigation Solution contains chlorhexidine gluconate as the active ingredient and the excipients:

  • methylene blue
  • octoxinol 8
  • water for injections.

Chlorhexidine 0.2% w/v Irrigation Solution contains chlorhexidine gluconate as the active ingredient and the excipients:

  • methylene blue
  • water for injections.

Supplier

Chlorhexidine Irrigation Solution is supplied in Australia by:

Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizer.com.au

Chlorhexidine Irrigation Solutions can be identified by an Australian Registration Number which is found on the packaging:

AUST R 11175

Chlorhexidine 0.1% Irrigation Solution 30 mL (sterile) Steritube® ampoule.

AUST R 11324

Chlorhexidine 0.2% Catheter Preparation Irrigation Solution 30 mL (sterile) Steritube® ampoule.

This leaflet was prepared in March/2020.

® = Registered Trademark

Published by MIMS June 2020

BRAND INFORMATION

Brand name

Pfizer (Perth) Chlorhexidine Irrigation Solution

Active ingredient

Chlorhexidine gluconate

Schedule

Unscheduled

 

1 Name of Medicine

Chlorhexidine gluconate.

6.7 Physicochemical Properties

Chlorhexidine gluconate solution is an almost colourless or pale yellowish liquid. It is miscible with water, soluble in acetone and in alcohol. The structural formula of chlorhexidine gluconate is represented:

Chemical structure.


Molecular Formula: C22H30Cl2N10,2C6H12O7.
Molecular Weight: 898.

CAS number.

18472-51-0.

2 Qualitative and Quantitative Composition

Chlorhexidine gluconate 30 mg/30 mL (0.1% w/v).
Chlorhexidine gluconate 60 mg/30 mL (0.2% w/v).

3 Pharmaceutical Form

Sterile blue coloured irrigation solution containing chlorhexidine gluconate in water for injections. The colouring agent is methylene blue. Chlorhexidine Irrigation Solution 0.1% w/v contains octoxinol 8 as a wetting agent.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Chlorhexidine is an antiseptic and disinfectant which is effective against a wide range of vegetative Gram positive and Gram negative organisms, some viruses and some fungi. It is ineffective against bacterial spores at room temperature, and acid fast bacteria are inhibited but not killed. It is more active against Gram positive than Gram negative bacteria and some species of Pseudomonas and Proteus are relatively less susceptible. Chlorhexidine is most active at a neutral or slightly acid pH and its activity may be reduced by blood and other organic matter.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

Chlorhexidine is not teratogenic in rats.

4 Clinical Particulars

4.1 Therapeutic Indications

Chlorhexidine Irrigation Solution 0.1% w/v.

For skin and wound irrigation or dressing to prevent and control infection.

Chlorhexidine Irrigation Solution 0.2% w/v.

For antisepsis of external genitalia prior to catheterisation of the bladder.

4.3 Contraindications

Known hypersensitivity to chlorhexidine.
Do not use to irrigate the brain, meninges, eyes or perforated eardrums.
Do not use in body cavities or as enema.

4.4 Special Warnings and Precautions for Use

For external use only. Not for injection, for irrigation only. Not isotonic and is haemolytic.
Not to be used as a preoperative skin preparation for face or head.

Use in the elderly.

No data available.

Paediatric use.

Use with care in neonates, particularly in premature infants. Chlorhexidine may cause irritation or chemical burns.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
Chlorhexidine has been used by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.
Based on negligible topical absorption and a complete lack of any unusual reported effects when used during pregnancy, chlorhexidine would not appear to present a risk to pregnant women. No special precautions or changes in methods of application or use of chlorhexidine seem needed in pregnant healthcare workers or patients.
No data available.

4.8 Adverse Effects (Undesirable Effects)

Irritative skin reactions and hypersensitivity reactions to chlorhexidine have been reported. In the event that these reactions occur, discontinue use.
Chlorhexidine may cause anaphylaxis.
Haematuria has been reported following bladder irrigation.
There have been at least four cases of irreversible corneal damage due to contact with chlorhexidine. Chlorhexidine has been reported to cause deafness when instilled into the middle ear through a perforated eardrum.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.2 Dose and Method of Administration

Chlorhexidine Irrigation Solution 0.1% w/v.

Rinse the area to be cleaned with water, apply the minimum amount of irrigation necessary to cover the wound area and wash gently. Rinse again thoroughly. Apply to wound as necessary. Discard remaining solution after use.

Chlorhexidine Irrigation Solution 0.2% w/v.

Irrigate the area of the external genitalia thoroughly prior to catheterisation.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.9 Overdose

For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

Symptoms and treatment.

In case of accidental or deliberate oral poisoning or ingestion.

Chlorhexidine taken orally is poorly absorbed. Immediate dilution with (120-240 mL) water or milk (not to exceed 15 mL/kg in children) is recommended. The administration of charcoal is not likely to be beneficial and may obscure visualisation during endoscopy. It is not recommended unless other substances known to be absorbed to charcoal are coingested. Employ supportive measures as appropriate.

In case of accidental intravenous administration.

Haemolysis due to hypotonicity has been reported. Blood transfusion may be necessary to counteract haemolysis.

7 Medicine Schedule (Poisons Standard)

Not scheduled.

6 Pharmaceutical Particulars

6.1 List of Excipients

Chlorhexidine Irrigation Solution 0.1% w/v: methylene blue, Octoxinol 8, water for injections.
Chlorhexidine Irrigation Solution 0.2% w/v: methylene blue, water for injections.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C. Protect from light. Single use only. Discard unused portion.

6.5 Nature and Contents of Container

Chlorhexidine 0.1% irrigation solution, 30 mL (sterile) Steritube ampoule.
Chlorhexidine 0.2% irrigation solution, 30 mL (sterile) Steritube ampoule.
Pack size: 30 units.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

Summary Table of Changes